FDA Allows More Comments on Draft Enforcement Policy on Unapproved Homeopathic Drugs

The Food and Drug Administration is extending the period for comments on its proposed new risk-based enforcement policy for unapproved homeopathic drugs. Under the policy, as described in a draft guidance issued Dec. 18 (see 1712190016), FDA would prioritize enforcement on unapproved drugs labeled as homeopathic based on their risk to human health, though “any product labeled as homeopathic that is being marketed illegally is subject to FDA enforcement action at any time,” the agency said. The draft guidance includes information on specific products and situations FDA will target in its enforcement activities. Comments are now due May 21.